Recall Of 1,000 Heart Devices Sought By U.s.

September 23, 1988|By John Gorman.

Federal prosecutors filed a civil suit Thursday that seeks the recall of more than 1,000 heart regulators manufactured by a Niles firm, saying that the devices are dangerous ``when used in the dosage, manner, or with the frequency`` prescribed in the labeling.

In a civil complaint filed against Medical Research Laboratories Inc., of 6547 W. Howard St., Niles, the U.S. attorney`s office seeks the recall of all defective defibrillators, which are used to stop irregular heart rhythm by applying a brief electroshock to the heart.

The suit asks a federal judge to order the recall and to enjoin the firm from further manufacturing and distribution until it is ``brought into full compliance with the law.``

During a press conference, U.S. Atty. Anton Valukas said the government is seeking the recall of the devices because they are ``in fact dangerous. . . . A (electrical) surge has the potential to be fatal.`` Valukas said there were no reports of any deaths from use of the devices.

The government seeks the recall of 1,000 Porta Pak 90 models and an undetermined number of model 450 SL defibrillators.

The Porta Pak 90 delivers an elecric shock through paddles placed either on the heart during open heart surgery or on the surface of the body, the suit says.

Valukas said the Food and Drug Administration repeatedly warned the firm that it was not following federal ``good manufacturing practice`` regulations for medical devices.

Medical research President Dean Milani, who said his firm ``makes the world`s finest medical equipment,`` said the firm has told users of the device to make certain they follow instructions in response to a recall order made three months ago. Charges that the devices can be dangerous even when used properly are ``just not true,`` he said.